Overview
Sr Associate Quality Assurance – Inspection PQA (3rd shift) Jobs in Juncos, PR at Amgen
Summary. Maintains Quality Assurance programs through accuracy, observation, reporting and recommendations to management. Acts as lead analyst for all environmental testing and reporting.
Essential Duties and Responsibilities. Include the following:
Supports all Quality Assurance requirements and procedures. Reports any deviations promptly to management.
Acts as primary contact for service providers.
Conducts daily and weekly equipment verifications.
Conducts QA checks of sanitizer and cleaning chemicals to ensure correct concentration.
Performs testing for allergens and monitors inventory of allergen swabs.
Coordinates with maintenance dept for building maintenance issues.
Performs swabbing of processing line and conducts processing line checks/bottle testing
Monitors and ensures that the facility’s pest control requirements are performed and maintained. Monitors the interior insect and rodent devices.
Conducts new hire training
Supports ISO14001 initiatives
Conducts facility GMP inspections and data collection
Conducts internal audits
Manages SOP updates for all departments.
Reviews and approves QA related raw material documentation in Trace Gains
Acts as contributing member of safety team
Performs clerical work as needed (scanning, filing, organizing)
Orders supplies as needed
Acts as a back-up for the QA specialist II as needed
Other duties may be assigned.
Qualifications. Education and/or Experience –Bachelor’s degree (B.A./B.S.) from four-year college or university preferred. Quality Assurance experience will be considered in lieu of four year degree.
Key skills: Proficiency in Microsoft Office required
Certificates, Licenses, Registrations. Food safety/HACCP certification desired, or training completed upon acceptance
Supervisory Responsibilities. This job has no supervisory responsibilities
Competencies. To perform the job successfully, an individual should demonstrate the following competencies:
Oral Communication – Listens and gets clarification; responds well to questions.
Teamwork – Contributes to building a positive team spirit.
Ethics – Treats people with respect; keeps commitment; works with integrity and ethically; upholds organizational values.
Organizational Support – Follows policies and procedures; completes administrative tasks correctly and on time; supports organization’s goals and values; supports affirmative actions and respects diversity.
Planning/Organizing – Prioritizes and plans work activities; uses time efficiently.
Professionalism – Approaches others in a tactful manner; reacts well under pressure; treats others with respect and consideration regardless of their status or position; accepts responsibility for own actions; follows through on commitments.
Quality – Demonstrates accuracy and thoroughness; monitors own work to ensure quality.
Safety and Security – Observes safety and security procedures; reports potentially unsafe conditions; uses equipment and materials properly.
Attendance/Punctuality – Is consistently at work and on time.
Dependability – Follows instructions, responds to management direction; takes responsibility for own actions; completes tasks on time or notifies appropriate person with an alternate plan.
Initiative – Volunteers readily.
Individual must be able to work overtime and alter their works hours as the job requirements dictate.
Language Skills – Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations. Ability to write reports, business correspondence, and procedure manuals. Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the public.
Mathematical Skills – Ability to calculate figures and amounts such as discounts, interest, commissions, proportions, percentages, area, circumference, and volume. Ability to apply concepts of basic algebra and geometry.
Reasoning Ability – Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.
Computer Skills – To perform this job successfully, an individual should have excellent Microsoft Office skills.
Physical Demands. While performing the duties of this job, the employee is regularly required to use hands to finger, handle, or feel and talk or hear. The employee is frequently required to reach with hands and arms, stand, walk, sit, and taste or smell. The employee must frequently lift and/or move under 60 pounds. Specific vision and hearing requirements required by this job include color vision and ability to hear sound.
Work Environment. While performing the duties of this job, the employee is regularly exposed to wet and/or humid conditions. The employee will regularly work near moving mechanical parts, be exposed to fumes or airborne particles and toxic or caustic chemicals. The noise level in the work environment is usually moderate.
We are an Equal Employment Opportunity (“EEO”) Employer.
Lucta is committed to the principles of equal employment and to complying with all federal, state, and local laws providing equal employment opportunities, and all other employment laws and regulations. It is our intent to maintain a work environment that is inclusive and equitable, free of harassment, discrimination, or retaliation based upon an individual’s age, race (including traits historically associated with race, which includes hair texture, hair type, and protective hairstyles such as braids, locks, and twists), color, national origin, ancestry, religion, sex, sexual orientation (including transgender status, gender identity, or expression), pregnancy (including childbirth, lactation, and related medical conditions), physical or mental disability, genetic information (including testing and characteristics), military status (including status as a uniformed servicemember, a veteran, or dependent of a servicemember), or any other status protected by federal, state, or local laws. Lucta is dedicated to the fulfillment of this policy regarding all aspects of employment, including but not limited to recruiting, hiring, placement, transfer, training, promotion, rates of pay and other compensation, termination, and all other terms, conditions, and privileges of employment.
Show more
Title: Sr Associate Quality Assurance – Inspection PQA (3rd shift)
Company: Amgen
Location: Juncos, PR
